Process Research & Development

Rather uniquely for a CRO, we have a highly experienced, dedicated group working at the Medicinal Chemistry/Chemical Development interface for our clients…

At the outset of our Discovery projects we encourage our clients to think ahead to the unique demands and challenges of Chemical Development, to ensure that pre-clinical supply can be forthcoming at the appropriate time point, and to speed up and reduce the costs of your clinical supply (see Chemistry World, September 2016, 35).

Charnwood Molecular’s PR&D team has over 100 years of combined large pharma experience. It provides excellence in pre-clinical Process Chemistry R&D and enables a smoother transition between Medicinal Chemistry and Chemical Development for our clients through the provision of focused early Development support programs which deliver:-

• Pre-clinical non-GMP supply (up to 0.5kg)
• Process Chemistry R&D to access efficient chemistry (High yields, robust, fast throughput)
• Enhancement of Out-licensing offering (including methods & samples)
• Increased value, de-risked project, API supply ensured
• Excellent Technology Transfer to cGMP Scale-up

To enable this, the Charnwood Molecular PR&D group has on-site access to state-of-art equipment including:

• Radleys Lara reactor system, 1-10L (for control key reaction scale-up parameters)
• Mettler Toledo DSC3 (for safety and stability testing)
• Mettler Toledo Karl-Fischer V10S system (for water content determinations of intermediates and final products)
• Technobis Crystal 16 benchtop crystallisation system (for crystallisation screens – salt forms/polymorphs – and solubility determinations)

As most Development activities are dependent on an adequate supply of API, it is important to keep the Chemical Development activities a phase ahead of the requirements of other departments. Although initial quantities of the API provide the fuel for the Development engine, ultimately, it is the quality of the manufacturing process that will be the most valuable output from the PR&D effort. Chemistry problems are solved more efficiently and economically in the laboratory rather than on plant, where costs increase 15-fold.

Effective PR&D saves time and costs in New Product Development. Inefficient chemistry can cost a project up to 18 months in time, negatively impacting New Product Value (NPV) by up to 30%. The 20-50kg campaign is often the real rate-limiting delivery stage, with a major impact on NPV. This needs to be considered early and Charnwood Molecular’s PR&D group can help you do this.

Please contact us directly if you have a project which might benefit from our involvement.

More information on our Chemical Development expertise can be found here:

Charnwood Molecular – Chemical Development Expertise